💊FDA Determines Heparin Sodium Products Not Withdrawn for Safety
Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The determination by the FDA allows for the approval of abbreviated new drug applications (ANDAs) for heparin sodium products, facilitating competition in the market and potentially reducing costs for consumers. This impacts businesses involved in pharmaceutical manufacturing and distribution.